AtheroMed's EASE Study for the Phoenix Atherectomy System Completes Enrollment

October 2, 2013 – AtheroMed, Inc. (Menlo Park, CA) announced that it has completed patient enrollment in the EASE clinical study, which is evaluating the company's Phoenix atherectomy system in the treatment of peripheral arterial disease (PAD).

On October 9, Stephen Williams, MD, will present results from the EASE study during a late-breaking clinical trials session at the VIVA 2013: Vascular Interventional Advances conference in Las Vegas. Dr. Williams is Director of the Vascular Medicine Center at Johns Hopkins University in Baltimore, Maryland.

According to the company, the EASE study was a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Phoenix system for the treatment of de novo and restenotic lesions of lower extremity arteries. The study was conducted under an investigational device exemption to support US Food and Drug Administration clearance.

The EASE investigators enrolled 105 patients at 16 sites in the United States and Germany. Outcome assessments were made after the baseline procedure and at 30-day and 6-month follow-up visits. The study's coprincipal investigators were Thomas Davis, MD, of St. John Hospital in Detroit, Michigan, and James McKinsey, MD, of Columbia Presbyterian Hospital in New York, New York.

In AtheroMed's press release, Dr. Davis commented, “Peripheral arterial disease, especially blockages located below the knee, continues to present challenges, even with currently available technologies. Based on my case results in the EASE study, the Phoenix atherectomy system appears promising as a front-line therapy for treating PAD.”

The company stated that the Phoenix peripheral atherectomy system has been specifically designed for the treatment of PAD located below the knee. It is an over-the-wire device with a front-cutting element at the distal tip of the catheter. The blade design of the rotating cutting element shaves material directly into the catheter, where the material is captured and continuously removed by an internal Archimedes screw that runs the length of the Phoenix catheter. The system has been designed in multiple sizes and is intended to provide physicians with a safe, versatile, easy-to-use frontline therapy. The Phoenix system has received European CE Mark approval and is commercially available outside of the United States. It is available for investigational use only in the United States, advised AtheroMed.